Louisiana Accident Attorney Blog

The FDA gave a regulatory warning to a vaccine manufacturer, involving multiple quality-control observations made after a review of the manufacturing plant in Pennsylvania.

The company, Merck, makers of the blockbuster selling human papilloma virus vaccine Gardasil. Also makers of a hepatitis A, two hepatitis B vaccines and the makers of Vioxx. According to news reports, the regulatory warning should not hamper the vaccine makers ability to sell the currently marketed product.

According to a number of news reports, the FDA's warning letter sent to Merck & Co. mentioned "significant deviations from current good manufacturing practice. . . in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components" at the plant based in Pennsylvania.

The letter was dated the 28th of April and is based on the FDA inspection covering November 2007 through January 2008. According to news reports, the FDA noted that certain lots of pediatric vaccines were recalled as a precautionary measure in December 2007, with production suspended, with distribution not expected to resume until the fourth quarter of 2008. One of the vaccines recalled were those chemically manufactured to prevent disease caused by Haemophilus influenza type B in infants.

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Posted In: Pharmaceutical Litigation

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65,000 F-Series Super Duty pickups are being recalled by the Ford Motor company.

The recall is being made so that the fuel-tank mounting can be strengthened in order to prevent a gasoline leak in a head on collision.

According to Ford, a front-end crash of 30 mph or more could cause the fuel tank to move forward, spilling fuel and possibly causing it to ignite.

The recall is affecting some 2008 F-250's and F-350 trucks, according to the National Highway Traffic Safety Administration website.

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Posted In: Product Liability

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Contact:
(800) 499-1976 – For Pfaltzgraff® Dinnerware
(866) 928-0060 – For Nautica® Dinnerware

FOR IMMEDIATE RELEASE -- April 28, 2008 -- Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff® Villa della Luna® pattern and Nautica J Class® pattern stoneware dinnerware products may exceed the Food and Drug Administration’s (“FDA”) guidance levels for lead and/or cadmium. No illness related to these products has been reported to date.

Specifically, the following products are subject to this recall:

Nautica J Class® Red Dinner Plates Villa della Luna® Dinner Plates
Nautica J Class® Red Salad Plates Villa della Luna® Soup/Cereal Bowls

These dinnerware products may have been sold as part of a set or individually online and through retail stores nationwide.

For additional information regarding the recall, please contact us by dialing the following toll free
numbers:
(800) 499-1976 – For Pfaltzgraff® Dinnerware
(866) 928-0060 – For Nautica® Dinnerware

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Contact:
Stericycle customer service
1-888-276-6166

FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United
States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use.

The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at their web site.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or
on the MedWatch website.

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Contact:
Marguerite Copel
(214) 721-1273

FOR IMMEDIATE RELEASE --Mount Crawford, Virginia -- April 23, 2008 --- WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein. The individual bottles are printed with both a "use by" date of May 7, 2008 (printed as 05 07 08) and a Universal Product Code (UPC) of 2529360028. Consumers can find this information on the back of the individual bottle.

People who have an allergy or severe sensitivity to milk protein run the risk of a health problem or illness if they consume this product. Some reactions have been reported.

This affected product was distributed nationwide and reached consumers through retail and foodservice outlets. WhiteWave's sales team is working with distributors to actively recover any affected product remaining on store shelves.

HOW TO IDENTIFY THE RECALLED PRODUCT

This recall includes only 11-ounce single serve plastic bottles of Silk Soymilk Chocolate Flavor with both a "use by" date of May 7, 2008 (printed as 05 07 08) and a UPC code of 2529360028.

Consumers should look for this information on the back of the bottle.

The Company apologizes for any inconvenience to its customers. Consumers who purchased the product may return it to the place of purchase for a full refund or exchange. Consumers with
questions can contact the Company at 1-800-587-2259.

The Food and Drug Administration has been notified of this recall.

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No illnesses reported, Consumers Urged to Discard Product

Contact:
Donna Rheaume
(617) 624-5006

FOR IMMEDIATE RELEASE -- Boston, MA -- April 19, 2008 -- The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).

The affected product is packaged in 12 ounce plastic bags, labeled under the Chang Farm brand
as Soy Sprouts, and have a "Sell By" date of April 19, 2008. At this time, DPH is aware of the affected product being distributed at several retail outlets throughout the state including Stop & Shop, Market Basket, and Whole Foods Markets.

Grocery stores, food service, and other retailers in Massachusetts should remove this product immediately. Consumers should discard this product or return it to the place of purchase.

To date, no illnesses associated with this product have been reported to DPH. L. monocytogenes is a bacteria that is widespread in the environment and is sometimes found in food. If contaminated food is eaten, it can result in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening illness.

Symptoms include fever, muscle aches, and sometimes nausea or diarrhea. The illness may be mild and the symptoms described as flu-like. While most cases of listeriosis occur in adults with weakened immune status, such as the elderly, pregnant women, and newborns, infections can occasionally occur in healthy individuals. Consumers should contact their healthcare provider with any illness concerns.

Consumers with questions about the warning may contact the DPH Food Protection Program at 617-983-6712.

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Thursday draft legislation released what is aimed at improving the safety of the nation's food and drug supply - new fees for food and drug companies.

The draft legislation says regulators should inspect food and drug makers more frequently, it was spearheaded by Rep. John Dingell, D-Mich. and other Democratic leaders of a powerful House committee.

If enacted, the proposal would lead to major changes in the drug and food oversight, and it was quick to draw rebukes.

The Grocery Manufactures Association vice president, Scott Faber said, "we should not be taxing food companies at a time of record food prices. Congress ought to provide the (Food and Drug Administration) with ample funding and not pass that cost on to companies and consumers."

The proposed legislation would require each facility that exports food to the USA would have to pay $2000 per facility per year to register. The fee would generate about $600 million, more than doubling the FDA's current food safety budget.

Every four years, the FDA would have to inspect food plants and those plants' food-safety plans. Lawmakers have said food plants, on average, get inspected once every 10 years.

The first hearing on the draft is set for April 24. Others are expected with final legislation to follow.

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Contact:
CDPH Complaint Hotline
1-800-495-3232

FOR IMMEDIATE RELEASE --Sacramento, CA -- April 17, 2008 --- Dr. Mark Horton, director of the California Department of Public Health (CDPH), today warned consumers not to eat Chaca Chaca Chacatrozo candy imported from Mexico after tests by CDPH found levels of lead that could cause health problems.

"Lead exposure can be harmful, especially for infants, young children and pregnant women," Horton said. "Today's warning is part of our ongoing efforts to ensure the safety of foods sold in California."

CDPH is working to identify distributors of Chaca Chaca Chacatrozo to ensure it is promptly removed from retail sale.

Consumers in possession of Chaca Chaca Chacatrozo should discard the candy. Pregnant women and parents of children who may have consumed this candy should consult their health care provider to determine if medical testing is needed.

Chaca Chaca Chacatrozo is a fruit pulp candy coated with a brownish-red colored salt and chili powder and is packaged in a clear plastic bag containing ten 50 grams individual candies. The net weight of the bag is 500 grams. The word "Chacatorzo" is printed at the top and bottom of the bag in white print outlined in blue. The front of the bag contains a white circle with a picture of a red locomotive. The words "Chaca Chaca" are printed in yellow across the locomotive.

Recent analysis by CDPH determined that Chaca Chaca Chacatrozo candy contained as much as 0.30 parts per million (ppm) of lead. California considers such products with lead levels in excess of 0.10 ppm to be contaminated.

For more information about lead poisoning, consumers are advised to contact their local childhood lead poisoning prevention program or public health department. Additional information and a list of local childhood lead prevention programs is available at http://www.cdph.ca.gov/healthinfo/discond/Pages/CLPPBChildrenAtRisk.aspx

Consumers who find Chaca Chaca Chacatrozo candy for sale are encouraged to call the CDPH Complaint Hotline at 1-800-495-3232. Photos of Chaca Chaca Chacatrozo are available here.

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In the later part of 2007, recalls and illness as a result of bacteria and E. coli O157:H7 soared - greater than any year since 2000.

2006 - There were eight recalls totaling 156,235 pounds of ground beef

2007 - There were twenty-one recalls of over 30million pounds of ground beef

Theories About Food-Borne Illnesses Rise

There are many theories why there is such a massive increase in the number of recalls and illnesses:

Better Reporting - more doctors are able to recognize the symptoms of E. coli, therefore leading to detecting outbreaks and forcing recalls.

Complacency - possibility of meat processors 'slacking off' causing them to be less likely to detect tainted beef.

Global Warming - The dry weather in the Southeast and Southwest may cause fecal dust to be blown and waft through the beef-slaughtering plants. In other regions where excessive rainfall causes muddy holding pens where E. coli will be more likely to thrive.

Other Pathogens

E. coli is one of the most popular bacterial agents to find its way into the media spotlight, there are also others agents that sicken the public. These would be salmonella, campylobacter, shigella and listeria. The nation has seen outbreaks of each of the illnesses. It was E. coli that sickened and killed many people who ate the tainted spinach in the beginning of 2007, and helped shut down food producer Topps. However, while it is primarily the stereotype, E. coli O157:H7 to blame there are other non-O157 toxins that are just as deadly, specifically 026, 0103, 0111, and 0145.

While most of these letters and numbers mean nothing to the average consumer, the implication is that there is more than one kind of E. coli that may rise in the future to harm and kill the public. The elderly and very young are susceptible to the illness and those with at risk immune systems; This should lead us to ask the question - "Why does this continue to happen and are there definitive ways to keep America's food supply safe?"

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Posted In: Foodborne Illness

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In recent documents that were examined and published on April 16, 2008 in an issue of JAMA, there were medical articles and court documents about rofecoxib. Rofcoxib, once marketed as Vioxx by Merck, is a nonsteroidal anti-inflammatory medication. It has become apparent that company employees or another unacknowledged author were often involved in writing the clinical trial and review articles, while primary authorship was awarded to academically affiliated investigators who may have been only peripherally related to the study.

In biomedical publications, authorship provides recognition for scientists' labors, while coincidentally establishing a direction for responsibility and accountability. Ghostwriting is the failure to recognize the individual who has made contributions to the work. Guest authorship can be rewarded in cases where authorship criteria is not met in certain publications, but may have still contributed considerable to the research or writing of a manuscript.

According to the authors of this study, "Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation." Joseph S. Ross, M. D., M. H. S. and colleagues, all of Mount Sinai School of Medicine, performed a case-study review of relevant medical literature, court documents and publicly available articles from MEDLINE to describe guest authorship and ghostwriting as related to rofecoxib. For this review, approximately 250 documents were used.

The clinical trials that were designed, conducted and sponsored solely by Merck, documentation was found describing affiliated scientists were often working to prepare manuscripts while consequently recruiting external, academically affiliated investigators to collaborate as guest authors. The authorship risk was assumed by these authors according to the authors in this study. "Recruited authors were frequently placed in first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors." At that time medical publishing companies would provide almost complete drafts to be reviewed by the authors for editing in addition to managing all submissions and revisions.

There is documentation describing Merck as compensating investigators with honorarium for agreeing to serve as authors on papers that had been ghostwritten for them by medical publishing companies. According to the study, of 96 relevant published articles, 92 percent (22 of 24) of clinical trial articles published a disclosure of Merck's financial support. Only 50 percent (36 of 72) of published review articles, either disclosed of Merck's sponsorship or disclosed whether the author had received any financial compensation from the company.

Indicated by the authors, there was a method to Merck's approach in publishing documents about rofecoxib. The case-study review of industry documents related to rofecoxib demonstrates that Merck strategically facilitated the publication of guest authors and ghost written medical literature. The doctors and scientists that conducted the study are hopeful that these findings encourage discussion of ways in which to improve the integrity of research. The medical profession and pharmaceutical industry should agree that collaborations must be conducted with the highest ethical standards. Academic researchers should consistently provide to the journals the author contributions for all manuscripts including the research, meta-analyses, reviews and commentaries. They should also disclose any relationship or support from all industry sources, regardless of the journal's requirements.

Authors of this study concluded that various methods by which this situation may be avoided in the future include: "Authors who 'sign-off' on or 'edit' original manuscripts or reviews written explicitly by pharmaceutical industry employees or by medical publishing companies should offer full authorship disclosure, such as 'drafting of the manuscript was done by representatives from XYX, Inc.; the authors were responsible for critical revisions of the manuscript for important intellectual content.' A coordinated oversight strategy involving academic physicians, journal editors, and industry representatives is necessary to discourage both guest authorship and ghostwriting and improve the integrity of the biomedical authorship system."

Quotes taken from www.medicalnewstoday.com
Guest Authorship and Ghostwriting Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation
Joseph S. Ross, MD, MHS; Kevin P. Hill, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM

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Posted In: Vioxx, Bextra & Celebrex

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Ford Motor Co. is recalling 2008 E-350's - 3,331 to be exact. The recalled trucks have a 138-inch wheelbase with a faulty drive shaft assembly.

The National Highway Traffic Administration (NHTSA) reported that "the drive shaft may have been manufactured with a slip yoke that has cracks." The flaw can reduce performance below design specifications.

Over time, the safety agency warns, the slip yoke could fracture without warning, allowing the drive shaft to separate from the vehicle, increasing the risk of a crash.

Once the recall begins, Ford dealers will inspect the E-350 drive shaft and replace it free of charge. Owners may contact Ford at 1-800-392-3673 or NHTSA at 1-888-327-4236 (TTY 1-800-424-9153).

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According to the FDA, at least 23 people in 14 states have been sickened by the same strain of salmonella found in two breakfast cereals recalled by Malt-O-Meal, the federal Food and Drug Administration and Saturday.

A case in Minnesota is being investigated to see if it is linked to the cereals being produced by the Minneapolis-based company, the state health department said.

The unsweetened Puffed Rice and Puffed Wheat cereals have voluntarily recalled Malt-O-Meal on April 5 after finding salmonella contamination during routine testing. The affected bags were produced in Northfield, Minnesota in the past 12 months.

Heidi Kassenborg, director of of the dairy and food inspection division of the Minnesota Department of Agriculture issued the following statement, "The Malt-O-Meal company has been extremely cooperative in this investigation and has done the right thing to protect the public's health.

According to the CDC, three people have been hospitalized, but no deaths have been reported.

Symptoms of salmonella infection include nausea, vomiting, diarrhea, fever and abdominal cramps. It can be life-threatening for people with poor health or weakened immune systems, including young children and the elderly.

The FDA said people who experience such symptoms after eating puffed wheat or puffed rice cereal made by Malt-O-Meal should contact their doctors and report the illness to the state or local health authorities.

The FDA said the recalled products were distributed nationally under the Malt-O-Meal brand name, as well as private labels including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereal bags have "best if used by" dates from April 8, 2008 (coded as APR0808), through March 18, 2009 (coded as MAR1809).

Consumers with products from the recalled lots are advised to throw them out, and retailers have been told to remove the cereals from their shelves.

The CDC said that as of Friday, it had received reports of 21 people ill with the same salmonella strain in 13 states. California reported 1; Colorado, 1; Delaware, 1; Maine, 3; Massachusetts, 2; Minnesota, 1; North Dakota, 1; New Hampshire, 2; New Jersey, 3; New York, 3; Pennsylvania, 1; Rhode Island, 1; and Vermont, 1.

It wasn't clear what the 14th state was and whether the two additional cases were from there.

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Posted In: Foodborne Illness

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